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ObesityASPIRENCT00967668

Coaching Veterans to Healthy Weights and Wellness

A study testing Small change approach to improve physical activity and diet in people with Obesity, run by US Department of Veterans Affairs at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

ASPIRE has completed enrollment of patients at the Ann Arbor and Cleveland Medical Centers in a study that is examining the impact of an innovative approach to weight loss ("Aspiring to Lifelong Health in VA", aka "ASPIRE-VA"). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
Small change approach to improve physical activity and diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
481 participants
Where
2 sitesUnited States
Study dates
Jan 2010to Dec 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Current patient at Ann Arbor or Cleveland medical center.
  • Current provider- or self-referral to MOVE! program and eligible to participate in MOVE!
  • 18 years of age and older
  • Able to communicate in English
  • Report being able to walk 10 minutes continuously without sitting down to rest
  • Competent to provide written informed consent

Who cannot join

  • Enrolled in another research study involving weight loss, nutrition, or physical activity
  • Being treated for weight loss or on weight loss medications (OTC or prescribed)
  • Are currently pregnant

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor, Michigan, 48105

  • VA Medical Center, Cleveland

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: ASPIRE: Coaching Veterans to Healthy Weights and Wellness

ASPIRE has completed enrollment of patients at the Ann Arbor and Cleveland Medical Centers in a study that is examining the impact of an innovative approach to weight loss ("Aspiring to Lifelong Health in VA", aka "ASPIRE-VA"). ASPIRE-VA has 3 key features: 1) lifestyle coaches who encourage behavior change through a "small steps" approach; 2) a simplified "Stoplight" diet; and 3) user-friendly "enhanced" pedometers to help participants monitor their physical activity.

Read the detailed description

Background:

Nearly 78% of Veterans are overweight or obese, imposing a tremendous burden on the Veterans Health Administration (VHA) healthcare system for the treatment of obesity-related chronic disease and disability. While weight management treatment has been implemented in VHA, program data shows low enrollment, participation, and weight loss. Traditional behavioral weight loss trials frequently exclude individuals with multiple chronic health conditions. Additionally, men are less likely than women to participate in these trials. New weight loss approaches may be needed to treat these populations.

Objectives:

To test whether a small-changes intervention (The Aspiring to Lifelong Health Program; aka ASPIRE), delivered in groups or individually via telephone, promotes greater weight loss than standard obesity treatment in a predominantly male, high-risk Veteran population. Data were collected in 2010-13.

Methods:

A three-arm, 12-month randomized pragmatic effectiveness trial was conducted. Participants were recruited from MOVE! referrals and randomly assigned to one of three programs: the 12-month ASPIRE weight loss program delivered 1) individually over the phone (ASPIRE-Phone) or 2) in-person group sessions (ASPIRE-Group); compared to 3) Veteran Health Administration's VHA standard weight loss program, MOVE!. Participants in the ASPIRE arms met with health coaches weekly in months 1-3, bi-weekly in months 4-9, and monthly in months 10-12. Usual care participants met weekly for 12 weeks with limited options for follow-up care. The ASPIRE program had distinct characteristics: 1) the opportunity for most participants to work with one lifestyle coach throughout treatment, 2) an emphasis on behavior change through a "small steps" approach; 3) the prominence of self-monitoring both physical activity and food intake as a weight loss tool; and 4) the addition of a purely phone based option. Assessments that included the collection of weight, waist circumference and lab values, along with questionnaires, were conducted at baseline, 3-months and 12-months. ASPIRE also added a follow-up component to the study, which was offered to patients at their 12-month assessment. For phone and group patients, it consisted of sessions every other month and an assessment at 18 and 24 months. Usual care patients participated in the assessments only.

Phone-based Interviews were conducted shortly after the 3-month assessment with 19 patients in the ASPIRE phone arm and with 16 in the ASPIRE group arm. These interviews were recorded, transcribed and analyzed using NVivo qualitative software to identify themes associated with successful weight loss at 3-month.

Approximately 5% of all phone and group intervention sessions were audio-recorded. An expert rater used a checklist to rate session fidelity. A second rater independently assessed 30% of the recorded sessions to establish inter-rater reliability. The checklist was psychometrically validated. It was hypothesized that greater adherence to core behavioral change processes and patient-centered communication strategies by the interventionists would be associated with higher levels of weight loss.

Using intention-to-treat principles guide all analyses. The primary outcome was weight change and secondary outcomes included changes in anthropometric (e.g., waist circumference), behavioral, fitness, psychosocial, and physiological measures. The primary analytic approach relied on a linear mixed-effects model with baseline, 3- and 12-month outcomes (e.g., weight) as dependent variables, with each subject as a random intercept to adjust for within-patient correlation of the repeated measures, fixed predictors of study arm indicators, 3- and 12-month time indicators, and time-by-study arm interactions.

Status:

All coaching and assessments are complete. A design and rationale paper has been published, a paper highlighting 12-month results is in revision. Papers on fidelity, qualitative findings, the role of mental illness and binge eating on weight loss are in progress. Analyses of 24-month data are underway.

Conditions
Obesity
Being tested
Small change approach to improve physical activity and diet, MOVE! Usual Care
Keywords
Counseling, Veterans, Weight loss, Physical activity, Diet
Medical subject headings
Obesity, Weight Loss, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Small change approach to improve physical activity and dietBehavioural

    The "Aspire to Lifelong Health" (ASPIRE) initial treatment program draws on the strengths of traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week in the program, participants use a food diary to track caloric intake and a pedometer to log their daily physical activity (step counts). Baseline information provides a starting point for participants and their Lifestyle Coach to set one small, but potentially permanent, change in daily food choices and physical activity to promote a caloric deficit. Small changes are cumulative over the weeks and the participant makes their own goals within the context of their own lifestyle.

  • MOVE! Usual CareBehavioural

    The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care.

Study groups in NCT00967668
Study groupRoleWhat they receive
ASPIRE-Phone Lifestyle CoachingExperimentalPhone-based coaching using small change approach to improve physical activity and diet. Initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA).
Receives: Behavioral: Small change approach to improve physical activity and diet
ASPIRE-Group Lifestyle CoachingExperimentalOn-site weekly group visits using small change approach to improve physical activity and diet. Initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA).
Receives: Behavioral: Small change approach to improve physical activity and diet
MOVE! Usual CareActive comparatorUsual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support
Receives: Behavioral: MOVE! Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Weight

    Expected weight change from baseline to 12 months in kilograms based on linear mixed-effects model using all available data

    Measured: 12 months after enrollment

Secondary outcomes (1)
  1. Change in Weight

    Expected weight change from baseline to 24 months in kilograms based on linear mixed-effects model using all available data. Statistical analyses methods are the same as for the 12-month outcome.

    Measured: 24 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionOct 2012
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
481 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00967668
Sponsor's protocol ID
IBB 09-034
Acronym
ASPIRE
Status last verified
Feb 2014
First submitted
26 Aug 2009
Last updated
24 Apr 2015
Data monitoring committee
Yes

Publications

  • Lutes LD, Dinatale E, Goodrich DE, Ronis DL, Gillon L, Kirsh S, Richardson CR, Damschroder LJ. A randomized trial of a small changes approach for weight loss in veterans: design, rationale, and baseline characteristics of the ASPIRE-VA trial. Contemp Clin Trials. 2013 Jan;34(1):161-72. doi: 10.1016/j.cct.2012.09.007. Epub 2012 Oct 4.

    PubMed 23041618
  • Damschroder LJ, Lutes LD, Kirsh S, Kim HM, Gillon L, Holleman RG, Goodrich DE, Lowery JC, Richardson CR. Small-changes obesity treatment among veterans: 12-month outcomes. Am J Prev Med. 2014 Nov;47(5):541-53. doi: 10.1016/j.amepre.2014.06.016. Epub 2014 Sep 10.

    PubMed 25217098
  • Janney CA, Masheb RM, Lutes LD, Holleman RG, Kim HM, Gillon LR, Damschroder LJ, Richardson CR. Mental health and behavioral weight loss: 24-month outcomes in Veterans. J Affect Disord. 2017 Jun;215:197-204. doi: 10.1016/j.jad.2017.03.003. Epub 2017 Mar 11.

    PubMed 28340446
  • Damschroder LJ, Goodrich DE, Kim HM, Holleman R, Gillon L, Kirsh S, Richardson CR, Lutes LD. Development and validation of the ASPIRE-VA coaching fidelity checklist (ACFC): a tool to help ensure delivery of high-quality weight management interventions. Transl Behav Med. 2016 Sep;6(3):369-85. doi: 10.1007/s13142-015-0336-x.

    PubMed 27528526
  • Vimalananda V, Damschroder L, Janney CA, Goodrich D, Kim HM, Holleman R, Gillon L, Lutes L. Weight loss among women and men in the ASPIRE-VA behavioral weight loss intervention trial. Obesity (Silver Spring). 2016 Sep;24(9):1884-91. doi: 10.1002/oby.21574. Epub 2016 Aug 4.

    PubMed 27488278
  • Masheb RM, Lutes LD, Kim HM, Holleman RG, Goodrich DE, Janney CA, Kirsh S, Higgins DM, Richardson CR, Damschroder LJ. Weight loss outcomes in patients with pain. Obesity (Silver Spring). 2015 Sep;23(9):1778-84. doi: 10.1002/oby.21160. Epub 2015 Aug 3.

    PubMed 26237112

Questions about this trial

What is this clinical trial studying?

A study testing Small change approach to improve physical activity and diet in people with Obesity, run by US Department of Veterans Affairs at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weight (time frame: 12 months after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00967668, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.

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